Menu Close

Safety and Tolerability of BufferGel, a Novel Vaginal Microbicide, in Women in the United States

Citation

Mayer, Kenneth H.; Peipert, Jeffrey; Fleming, Thomas; Fullem, Andrew M.; Moench, Thomas; Cu-Uvin, Susan; Bentley, Margaret E.; Chesney, Margaret A.; & Rosenberg, Zeda (2001). Safety and Tolerability of BufferGel, a Novel Vaginal Microbicide, in Women in the United States. Clinical Infectious Diseases, 32(3), 476-82.

Abstract

BufferGel (ReProtect, LLC) is a vaginal gel with an acidic buffering action that was designed to prevent vaginal neutralization by semen. The purpose of this study was to evaluate the safety and tolerability of BufferGel (ReProtect, Limited Liability Company) applied vaginally either once or twice daily by 27 women who were at low risk for acquisition of human immunodeficiency virus (HIV). Participants initially used the product once daily for 14 days and then twice daily for 14 days; they underwent colposcopy before and after product exposure. BufferGel was well tolerated, although two-thirds of the participants reported at least 1 mild or moderate adverse experience. The most common adverse events were irritative genitourinary symptoms. Product use was discontinued after 3 adverse events. BufferGel was well tolerated in women at low risk for acquisition of HIV; toxicity was limited and occurred at frequencies similar to those in women who did not use any vaginal product and at levels lower than in women who used detergent-based microbicides.

URL

http://dx.doi.org/10.1086/318496

Reference Type

Journal Article

Journal Title

Clinical Infectious Diseases

Author(s)

Mayer, Kenneth H.
Peipert, Jeffrey
Fleming, Thomas
Fullem, Andrew M.
Moench, Thomas
Cu-Uvin, Susan
Bentley, Margaret E.
Chesney, Margaret A.
Rosenberg, Zeda

Year Published

2001

Volume Number

32

Issue Number

3

Pages

476-82

Reference ID

1654